A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01288911
First received: February 1, 2011
Last updated: February 10, 2016
Last verified: February 2016
  Purpose
The purpose of this study is to determine the efficacy and safety of oral enzalutamide compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy.

Condition Intervention Phase
Prostatic Neoplasms
Drug: enzalutamide
Drug: Bicalutamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Progression Free Survival (PFS) Based on Independent Central Review (ICR) Assessment [ Time Frame: From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ] [ Designated as safety issue: No ]

    PFS is the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by the ICR, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first.

    Radiographic disease progression was defined as either a progression in soft tissue on computed tomography (CT)/magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan.

    A skeletal-related event was any radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain.

    The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started.



Secondary Outcome Measures:
  • PFS Based on Investigator Assessment [ Time Frame: From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ] [ Designated as safety issue: No ]

    PFS was calculated as the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by investigators, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first.

    Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan.

    A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain.

    The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started.


  • Prostate-specific Antigen (PSA) Response by Week 13 [ Time Frame: Baseline to Week 13 ] [ Designated as safety issue: No ]
    The PSA response by Week 13 was defined as the percentage change from Baseline to the smallest PSA value after Baseline (i.e., a decrease of 100% represents the largest possible decrease to a value below the lower limit of quantification) and on or before day 99 (i.e., upper boundary of the Week 13 visit window). For participants with no decrease in PSA post-baseline by Week 13, the PSA response by Week 13 was the smallest increase in PSA up to day 99. For participants with no post-baseline PSA values up to day 99, the PSA response by Week 13 was set to missing. PSA was analyzed at a central laboratory.

  • Best Prostate-specific Antigen (PSA) Response [ Time Frame: Baseline to the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ] [ Designated as safety issue: No ]
    The best PSA response was defined as the percentage change from Baseline to the smallest PSA value after Baseline including PSA results from samples taken after the study drug was stopped. For participants with no decrease in PSA post-baseline, the best PSA response was the smallest increase in PSA. For participants with no post-baseline PSA values, the PSA response was set to missing. PSA was analyzed at a central laboratory.

  • Time to PSA Progression [ Time Frame: From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ] [ Designated as safety issue: No ]
    Time to PSA progression was calculated as the time interval from the date of randomization to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir (or above the baseline value for patients who did not have a decline in PSA post-baseline values), and confirmed by a second consecutive PSA assessment at least 3 weeks later. For participants with no documented PSA progression, the time to PSA progression was censored on the date the last PSA sample was taken.

  • Time to PSA ≤ 4 ng/mL [ Time Frame: From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ] [ Designated as safety issue: No ]
    Time to PSA ≤ 4 ng/mL was defined as the time interval from the date of randomization to the first date a decline in PSA to a result of 4 ng/mL or below was recorded. In participants without PSA results ≤ 4 ng/mL, the time to PSA ≤ 4 ng/mL was censored on the date of the last PSA sample taken. Participants with a PSA result ≤ 4 ng/mL at Baseline, participants with no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization

  • Time to ≥ 30% PSA Decline From Baseline [ Time Frame: From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ] [ Designated as safety issue: No ]
    The time to ≥ 30% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 30% was recorded. In participants without ≥ 30% PSA decline from Baseline, the time to ≥ 30% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization

  • Time to ≥ 50% PSA Decline From Baseline [ Time Frame: From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ] [ Designated as safety issue: No ]
    The time to ≥ 50% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 50% was recorded. In participants without ≥ 50% PSA decline from Baseline, the time to ≥ 50% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization

  • Time to ≥ 90% PSA Decline From Baseline [ Time Frame: From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ] [ Designated as safety issue: No ]
    The time to ≥ 90% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 90% was recorded. In participants without ≥ 90% PSA decline from Baseline, the time to ≥ 90% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization

  • Radiographic PFS Based on ICR Assessment [ Time Frame: From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ] [ Designated as safety issue: No ]

    Radiographic PFS was calculated as the time interval from the date of randomization to the first date of radiographic disease progression.

    Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions (a minimum of 2 new bone lesions as compared to previous scan) on bone scan and confirmed by the next bone scan.


  • Percentage of Participants With an Objective Response [ Time Frame: From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ] [ Designated as safety issue: No ]

    Response assessments were reported by ICR for target lesions in soft tissues and non-target lesions in soft tissues based on CT and/or MRI according to RECIST version 1.1.

    Objective response was defined as the number of participants achieving either a complete response (CR) or a partial response (PR) based on participant's best overall response assessed at the end of the treatment.


  • Percentage of Participants With Adverse Events [ Time Frame: From initiation of study drug up to 30 days after the last dose of study drug or the 30-day safety follow-up visit, whichever occurred last. Median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm. ] [ Designated as safety issue: No ]

    A serious adverse event was defined as any untoward medical occurrence that at any dose:

    • Resulted in death
    • Was life threatening
    • Resulted in persistent or significant disability/incapacity
    • Resulted in congenital anomaly or birth defect
    • Required inpatient hospitalization or led to prolongation of hospitalization
    • Other medically important events.

    Treatment-related indicates adverse events assessed by the Investigator as probably or possibly related to study treatment.



Enrollment: 375
Study Start Date: March 2011
Estimated Study Completion Date: June 2016
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide
Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
Drug: enzalutamide
capsules
Other Name: MDV3100
Active Comparator: Bicalutamide
Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
Drug: Bicalutamide
tablets
Other Name: Casodex

Detailed Description:
An open-label period has been added to the main protocol. Following unblinding at the end of the double-blind period and demonstration of a statistically significant advantage of enzalutamide over bicalutamide as assessed by the primary endpoint, all ongoing enzalutamide treated participants and ongoing or previous bicalutamide treated participants that meet entry criteria will be offered open-label enzalutamide at the discretion of the participant and study investigators.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
  • Ongoing androgen deprivation therapy with a Luteinizing Hormone Receptor Hormone (LHRH) agonist or antagonist at a stable dose and schedule within 4 weeks of randomization or bilateral orchiectomy (i.e., surgical or medical castration)
  • Metastatic disease documented by one of the following:

    • At least two bone lesions on bone scan, or
    • Soft tissue disease documented by computed tomography (CT)/ magnetic resonance imaging (MRI), or
    • Unequivocal pelvic adenopathy short axis > 2.0 cm in diameter by CT/MRI
  • Progressive disease at study entry defined as one or more of the following three criteria occurring in the setting of castrate levels of testosterone:

    • Prostate Specific Antigen (PSA) progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value should be ≥ 2 µg/L (2 ng/mL);
    • Soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
    • Bone disease progression defined by two or more new lesions on bone scan
  • Asymptomatic or mildly symptomatic from prostate cancer (i.e. the score on the Brief Pain Inventory-Short Form (BPI-SF) Question #3 must be < 4); no use of opiate analgesics for prostate cancer-related pain currently or anytime within 4 weeks prior to randomization
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, including subjects with decreased performance status not attributed to progressive and symptomatic prostate cancer
  • Estimated life expectancy of ≥ 12 months
  • Able to swallow the study drug and comply with study requirements
  • A male subject and his female spouse/partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at Screening and continuing throughout the study period, and for 3 months after final study drug administration. Two acceptable forms of birth control include:

    1. Condom (barrier method of contraception), AND
    2. In addition to a condom, one of the following acceptable forms of contraception is required:

      • Established use of oral, injected or implanted hormonal methods of contraception.
      • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
      • Barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
      • Tubal ligation for at least 6 months prior to Screening
      • Vasectomy or other surgical castration at least 6 months prior to Screening

Exclusion Criteria:

  • Prior cytotoxic chemotherapy for prostate cancer
  • Severe concurrent disease, infection, or comorbidity that would make the subject inappropriate for enrollment
  • Known or suspected brain and/or skull metastasis or active epidural disease
  • History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
  • Current or prior treatment with estrogens and/or drugs with anti-androgenic properties such as spironolactone > 50 mg/day, or progestational agents for the treatment of prostate cancer within 6 months prior to randomization
  • Current or prior use of ketoconazole for the treatment of prostate cancer
  • Use of antiandrogens within 6 weeks prior to randomization
  • Documented prior disease progression while receiving antiandrogens. Disease progression defined as PSA progression, radiographic progression and/or clinical deterioration.
  • Current or prior treatment with 5-α reductase inhibitors or anabolic steroids within 6 months prior to randomization
  • Prior use of systemic glucocorticoids (the equivalent of 10 mg of prednisone) within 3 months prior to randomization or expectation of their use during the study
  • Radiation therapy to bone lesions or prostatic bed within 4 weeks prior to randomization
  • Major surgery within 2 months prior to randomization
  • History of seizure including febrile seizure or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization). Also, current or prior treatment with anti-epileptic medications for the treatment of seizures or history of loss of consciousness or transient ischemic attack within 12 months prior to randomization
  • Clinically significant cardiovascular disease including myocardial infarction within past six months or uncontrolled angina within past three months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288911

  Hide Study Locations
Locations
United States, Alabama
Site US1934 Urology Centers of Alabama, PC
Birmingham, Alabama, United States, 35209
United States, Alaska
Site US1527 Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States, 99508
United States, California
Site US2977 Beaver Medical Group, L.P.
Highland, California, United States, 92346
Site US3630 Genesis Research
San Diego, California, United States, 92123
United States, Colorado
Site US2935 Urology Center of Colorado
Denver, Colorado, United States, 80211
United States, Connecticut
Site US2945 Connecticut Clinical Research Center, LLC
Middlebury, Connecticut, United States, 06762
United States, Illinois
Site US2014 Midwest Urology/RMD Clinical Research
Melrose Park, Illinois, United States, 60160
Site US2067 Springfield Clinic, LLP
Springfield, Illinois, United States, 62703
United States, Indiana
Site US2027 First Urology, PSC
Jeffersonville, Indiana, United States, 47130
United States, Iowa
Site US1838 The Iowa Clinic PC, Urology
West Des Moines, Iowa, United States, 50266
United States, Kansas
Site US62 University of Kansas Medical Center
Westwood, Kansas, United States, 66205
United States, Maryland
Site US2976 University of Maryland
Baltimore, Maryland, United States, 21201
Site US3182 Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
United States, Michigan
Site US2975 University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109
Site US892 Spectrum Health Medical Group
Grand Rapids, Michigan, United States, 69546
United States, Minnesota
Site US20 University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Montana
Site US3078 Billings Clinic
Billings, Montana, United States, 59101
United States, New Jersey
Site US2968 AdvancedMed Research
Lawrenceville, New Jersey, United States, 08648
United States, New York
Site US3025 Hudson Valley Urology, PC
Poughkeepsie, New York, United States, 12601
Site US1675 University of Rochester Medical Center
Rochester, New York, United States, 14642
Site US2934 Staten Island Urological Research, PC
Staten Island, New York, United States, 10304
United States, North Carolina
Site US81 University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27599
Site US2104 Urology Center, PA
Greensboro, North Carolina, United States, 27403
United States, Ohio
Site US44 University of Cincinnati
Cincinnati, Ohio, United States, 45267
Site US2185 Columbus Urology Research, LLC
Columbus, Ohio, United States, 43220
United States, Pennsylvania
Site US1598 Urology Consultants of Southeastern Pennsylvania
Bala Cynwyd, Pennsylvania, United States, 19444
Site US1680 Lancaster Urology
Lancaster, Pennsylvania, United States, 17604
United States, South Carolina
Site US2926 Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Site US1657 Urology Associates, PC
Nashville, Tennessee, United States, 37209
United States, Texas
Site US464 Baylor College of Medicine (BCM)
Houston, Texas, United States, 77030
Site US2978 Urology San Antonio Research, PA
San Antonio, Texas, United States, 78229
United States, Virginia
Site US1653 Urology of Virginia/Sentara Medical Group
Norfolk, Virginia, United States, 23502
United States, Washington
Site US1580 Seattle Urology Research Center
Burien, Washington, United States, 98166
Site US1709 Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Site US51 Medical College of Wisconsin, Milwaukee
Milwaukee, Wisconsin, United States, 53226
Belgium
Site BE3015 Universitair Ziekenhuis Brussel
Brussel, BE, Belgium, 1090
Site BE3288 Universitaire Ziekenhuizen Leuven
Leuven, Brabant, Belgium, 3000
Site BE1322 Gent University Hospital
Gent, Belgium, 9000
Site BE3289 CHU de Liege
Liege, Belgium, 4000
Site BE3013 Algemeen Ziekenhuis Turnhout vzw
Turnhout, Belgium, 2300
Site BE3018 AZ Groeninge, Campus Vercruyss
West Flanders, Belgium, 8500
Canada, Alberta
Site CA3104 Prostate Cancer Centre
Calgary, Alberta, Canada, T2V 1P9
Canada, British Columbia
Site CA3242 Exdeo Clinical Research, Inc
Abbotsford, British Columbia, Canada, V2S 3N6
Canada, Ontario
Site CA2646 Kingston General Hospital
Kingston, Ontario, Canada, K7L 3J7
Site CA166 Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Site CA3084 University Health Network/Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Site CA2984 Theradev Clinical Research
Granby, Quebec, Canada, J2G 8Z9
Site CA170 Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Denmark
Site DK3354 Urologisk Axdeling Aalborg Sygelius
Aalborg, Denmark, 9000
Site DK3356 University Hospital of Aarhus, Skejby
Aarhus, Denmark, 8200
Site DK1857 Rigshospitalet
Copenhagen, Denmark, 2200
Site DK1263 Herlev University Hospital
Herlev, Denmark, 2730
France
Site FR1091 Hopital Henri Mondor
Creteil, France, 94010
Site FR3009 Hopital Claude Huriez
Lille Cedex, France, 59037
Site FR442 Hopital Edouard Herriot
Lyon Cedex 3, France, 69437
Site FR3002 Hopital TENON
Paris, France, 75020
Site FR3003 Centre Hospitalier Universitaire La Miletrie
Poitiers Cedex, France, 86021
Site FR3000 CHRU de Pontchaillou
Rennes Cedex, France, 35033
Site FR3007 CHU Rouen
Rouen, France, 76031
Site FR3005 Hospital Foch
Suresnes Cedex, France, 92151
Germany
Site DE2989 Aachen University / Dept. of Urology
Aachen, Germany, 51074
Site DE2993 Bonn University / Dept. of Urology
Bonn, Germany, 53105
Site DE2995 Medizinisches Zentrum Bonn
Bonn, Germany, 53111
Site DE2994 Urologie Bonn Rhein-Sieg
Bonn, Germany, 53117
Site DE3287 Marienkrankenhaus GmbH
Gladbach, Germany, 51465
Site DE2990 Medizinzentrum Hammoniabad / Urologikum Hamburg
Hamburg, Germany, 22081
Site DE3270 Medizinische Hochschule Hannover
Hannover, Germany, 30625
Site DE4000 Studienpraxis Urologie
Nurtingen, Germany, D-72622
Site DE2992 Urologische Gemeinschaftspraxis Reutlingen
Reutlingen, Germany, 72764
Site DE3286 Urologie am Hochrhein
Waldshut-Tiengen, Germany, 79761
Site DE2988 Die Gesundheits Union
Wuppertal, Germany, 42103
Romania
Site RO3042 Institutul Clinic de Uronefrol
Bucharest, Romania, 022328
Site RO3039 Spiatlul Clinic Th. Burghele
Bucharest, Romania, 50659
Site RO3035 Dinu UROMEDICA S.C.M.
Bucharest, Romania, 41345
United Kingdom
Site GB3244 Belfast City Hospital
Belfast, United Kingdom, BT9 7A
Site GB3029 Bristol Royal Infirmary Hospital
Bristol, United Kingdom, BS2 8NW
Site GB2702 Addenbrookes Hospital
Cambridgeshire, United Kingdom, CB2 0QQ
Site GB3028 University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Site GB3166 Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Site GB3290 Rosemere Cancer Centre
Lancashire, United Kingdom, PR2 9HT
Site GB1862 Leicester General Hospital
Leicester, United Kingdom, LE3 4PW
Site GB3163 University College Hospital
London, United Kingdom, NW1 2PG
Site GB3027 Guys Hospital
London, United Kingdom, SE1 9RT
Site GB3030 St. Georg's University of London
London, United Kingdom, SW17 0QT
Site GB3245 Mount Vernon Cancer Centre
London, United Kingdom, HA6 2RN
Site GB2624 The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Site GB3355 Clatterbridge Center for Oncology
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Astellas Pharma Inc
Medivation, Inc.
Investigators
Study Director: Associate Medical Science Director Astellas Pharma Global Development
Principal Investigator: Principal Investigator Carolina Urologic Research Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01288911     History of Changes
Other Study ID Numbers: 9785-CL-0222  2010-021868-15 
Study First Received: February 1, 2011
Results First Received: October 15, 2015
Last Updated: February 10, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Romania: National Medicines Agency
Denmark: Danish Health and Medicines Authority
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
MDV3100
Prostate
Cancer
Metastatic
progressive
enzalutamide

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2016